The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry.

EDITOR'S DESK

In most cases, the biosimilar guidelines put forth by all the major regulatory agencies are quite similar. But there are some differences that can challenge companies looking to have their biosimilars approved in these different countries.

As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.

During my time covering biosimilars, I’ve grown well-versed in some of these arguments, including those around naming, labeling, and reimbursement. But several discussions in the past few months have added new layers of complexity to these issues.

GUEST CONTRIBUTORS

The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) recently released two reports that contain nuggets of interest to those who are watching for trends in the pharmaceutical industry.

The challenges of comparing conventional colony forming units (CFUs) to newer technologies that are capable of counting individual cells or measuring different variables/factors (such as light, shape, or fluorescence) has limited the acceptance and implementation of new technologies in the pharmaceutical industry.

Over the last 35 years, the biopharmaceutical industry has accepted, as part of an ongoing process, a wide range of single-use system (SUS) technologies. Initial adoption of filter capsules and plastic tubing has grown in complexity and scale from the early 1980s through today. Now, manufacturers are able to replace most hardware components, including stainless steel vessels/piping/sanitary flanges, and glass vessels, with single-use polymeric devices and components. Thanks to a large and diverse offering of single-use products, what was once primarily an upstream technology has begun expanding into downstream processes.

In 2013, the United States enacted pharmaceutical serialization and traceability requirements under the Drug Supply Chain Security Act (DSCSA). In the years preceding and following passage of the DSCSA, many other countries considered similar regulation for their own markets. Argentina, China, India, South Korea, and Turkey currently require the serialization of pharmaceutical products and the reporting of some type of serialization data. Approximately 40 additional countries — including the U.S., the European Union, Brazil, Russia, and multiple Persian Gulf states — have enacted requirements with future implementation dates or are actively working on requirements.

In the pharmaceutical and biologics manufacturing community, we’ve been instilled with a unified and rigorous direction with respect to capital project execution. The emphasis is speed, and rightfully so. These projects are among the most complex and costly in facility construction; not to mention that, given the revenue at risk, the overarching focus on speed to market is undeniable. Understandably, the best methodologies of project management — with all its sophisticated tools of the most current thinking — are brought to bear. A strong focus on linear forward progress is always at the fore: initiate, achieve goal one, then goal two … finally finish.

BIOPROCESSING WHITE PAPERS

Great hopes and expectations are linked to stem cells as a tool for drug discovery and to stem cell-derived products in therapeutic applications. Though several products have made it to commercial stage, most of the research is still performed in small scales using simple cultivation systems such as spinner flasks or T-flasks.

As the pharmaceutical industry implements PAT and QbD, their symbiotic nature becomes increasingly obvious. Both are catalysts towards the longer term goals of continuous operation and real-time release — the realization of a transformed way of working. This article reviews changing practice within the pharmaceutical industry using the example of real-time particle size analysis to explore the analytical solutions needed and the benefits they deliver. By Malvern Instruments

INDUSTRY INSIGHTS

The success of any biologic drug, for example, monoclonal antibodies (mAbs), recombinant proteins, or biosimilars, depends greatly on downstream purification. Among the challenges process scientists often face during this process is the formation and/or removal of aggregates of monomers.

In May 2013 the U.S. Food and Drug Administration (FDA) released its draft guidance, “Contract Manufacturing Arrangement for Drugs: Quality Agreements,” with recommendations representing its “current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP). In particular, we describe how parties involved in the contract manufacturing of drugs can utilize Quality Agreements to delineate their responsibilities and assure drug quality, safety, and efficacy.”

The US Food and Drug Administration (FDA) is responsible for issuing 483 observations to life sciences companies if routine audits find violations, production or quality issues which raise concerns to the safety of the general public. With news stories regularly documenting that an increasing number of organizations are being issued with FDA-483s, often with serious outcomes, avoiding these warnings is a priority and necessitates an understanding of industry requirements, the use of appropriate tools and conducting comprehensive audits.

Systems should be analyzed not only for their basic ability to contain the powders of interest, but also for how efficiently they integrate into the production process. For instance, will the system help to eliminate productivity bottlenecks, decrease material waste and the cost of raw materials, and simplify the changeover of the line to new products?